Clinical Research Assistant

Position Summary

Experienced Medical Assistant or Research Assistant needed to contribute to Urology Austin’s growing research department. Research Assistant (RA) roles often transition to Clinical Research Coordinator (CRC) roles and open the door to many other career opportunities within the industry. Research Assistants support the Clinical Research Team with subject recruitment, diagnostic testing, laboratory specimen collection, communications with patients, study sponsors, and investigators, and other interesting research related roles.

Experienced Medical Assistant or Research Assistant needed to contribute to Urology Austin’s growing research department. Research Assistant (RA) roles often transition to Clinical Research Coordinator (CRC) roles and open the door to many other career opportunities within the industry. Research Assistants support the Clinical Research Team with subject recruitment, diagnostic testing, laboratory specimen collection, communications with patients, study sponsors, and investigators, and other interesting research related roles.

You will work closely with our Study Coordinators, Clinical Research Director, Principal Investigators (PI) and Sub-Investigators (Sub-Is) on various clinical research studies.

• Reports to the Director of Clinical Research, VP of Clinical Research, Market President, and all the physicians at Urology Austin
• Able to collaborate with experienced patient navigators, IT, and data management teams

• Must be willing to gain a thorough knowledge and follow strict adherence of all clinical study protocols.
• Develop an understanding of and demonstrate Good Clinical Practices (GCPs), learn and comply with all FDA clinical trial and IRB rules and regulations
• Must have > 1 year experience as a medical assistant or research assistant.
• Urology based clinical experience preferred
• Should possess or develop proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems, and study specific EDC and IVRS systems
• Effective time management and the ability to prioritize work
• Excellent communication skills and the ability to interact with all levels of management, staff, and physicians in person, virtually, and in writing
• Ability to be flexible with the day-to-day job requirements to facilitate a successful workflow in clinic

• Review and follow Urology Austin Standard Operating Procedures
• Read and understand specific requirements of each study protocol and informed consent form
• Works with study coordinators and other research team members to complete protocol specific procedures and documentation
• Assists in clinic and protocol administration duties including but not limited to:
• Explain the purpose, risks, and benefits of clinical trial participation
• Screen potential candidates in a timely and accurate manner
• Ensure that study patients understand the information presented and agree to the protocol requirements
• Obtain and maintain consent of patients prior to any study-related procedures being performed and with the highest ethical standards
• Provide instructions to patients to ensure proper protocol compliance
• Distribute study medications in compliance with protocol randomization requirements
• Learn and understand lab procedures and obtain and process study related lab specimens according to the study specific manuals (lab and procedural)
• Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirements

• Perform study-specific readings and measurements…